Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients

Phase 1 Completed 11 enrolled ISU Abxis Co., Ltd. Catalyst Biosciences · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

This study is a phase 1, open-label, multi-center, dose-escalation study to investigate the safety, pharmacokinetics and pharmacodynamics of ISU304/CB2679d in previously treated hemophilia B patients.

Timeline

Start: 2017-06-03
Primary completion: 2018-10-10
Completion: 2019-02-22

Publications

Faraj A, Le Moan N, Gorina E, Blouse GE, Knudsen T, Simonsson USH. Model-Informed Support of Dose Selection for Prophylactic Treatment with Dalcinonacog Alfa in Adult and Paediatric Hemophilia B Patients. Adv Ther. 2023 Sep;40(9):3739-3750. doi: 10.1007/s12325-023-02570-6. Epub 2023 Jun 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BeneFIX	Protein / enzyme biologic	75 iu/kg	Intravenous
Subject	ISU304	Protein / enzyme biologic	75 iu/kg	Intravenous
Subject	ISU304	Protein / enzyme biologic	150 iu/kg	Intravenous

Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients

Summary

Timeline

Publications

Drugs

Indications